Phase 3 Myeloma Trial, Recruiting NCT05623020 Sponsor: Pfizer Condition: Myeloma
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Phase 3 Myeloma Trial, Recruiting

NCT05623020
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with multiple myeloma (a type of blood cancer) according to established medical guidelines.
  • People whose multiple myeloma is measurable through specific blood, urine, or protein tests meeting set thresholds (confirm with trial site for exact values).
  • In Part 1 of the trial: People whose multiple myeloma has come back or stopped responding to treatment, and who have received 1–2 previous rounds of treatment including at least one drug from each of two specific medication classes; OR people newly diagnosed with multiple myeloma who are not suitable candidates for a stem cell transplant, either because they are 65 or older, or because they are younger but have other health conditions that make a transplant unsuitable.
  • In Part 2 of the trial: People newly diagnosed with multiple myeloma who are not suitable candidates for high-dose chemotherapy and stem cell transplant, either due to age or due to other significant health conditions that could affect how well they tolerate those treatments.
  • People who are reasonably well and able to carry out basic daily activities, as measured by a standard health scoring system (score of 2 or lower on the ECOG scale).
  • People who are not pregnant and who are willing to use contraception during the trial.
  • For people whose myeloma has returned or stopped responding: People whose side effects from previous treatments have resolved or reduced to a mild level before joining.

Who may not be able to join:

  • People who have smouldering multiple myeloma (an early, inactive form of the disease).
  • People who have a condition called monoclonal gammopathy of undetermined significance (MGUS), which is a pre-cancer blood condition.
  • People who have Waldenström's macroglobulinaemia (a different type of blood cancer).
  • People who have plasma cell leukaemia (a rare and aggressive blood cancer).
  • People who have an active, uncontrolled infection — including bacterial, fungal, or viral infections such as COVID-19, hepatitis B or C, HIV, or AIDS-related illness.
  • People who have had another active cancer within the past 3 years, with exceptions for certain low-risk skin cancers or very early-stage cancers that have been fully treated (confirm with trial site).
  • For people whose myeloma has returned or stopped responding: People who have received certain specific targeted treatments (directed at BCMA or CD38) within the 6 months before starting this trial, or who have had a stem cell transplant within the past 3 months, or who are experiencing complications from a previous transplant.
  • For people newly diagnosed with multiple myeloma: People who have already received systemic (whole-body) treatment for myeloma, except for a limited short course of a steroid medication; or people who have received above a set cumulative dose of steroid medication during the screening period.
  • People who have received a live vaccine (such as some flu or travel vaccines) within 4 weeks before the first dose of the trial treatment.
  • People who have taken part in another clinical trial or received an experimental treatment within 30 days before starting this trial (or within a timeframe set by local requirements).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Pfizer CT.gov Call Center, Pfizer

Phone: 1-800-718-1021

Australian sites

Pindara Private Hospital, Benowa, Queensland
St Vincent's Hospital Melbourne, Fitzroy, Victoria
Epworth Freemasons, Melbourne, Victoria
The Alfred Hospital, Melbourne, Victoria
Epworth Healthcare, Richmond, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
10 November 2022
Est. completion
18 October 2030

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland Puerto Rico 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1 Dose Limiting Toxicity; Part 2: Progression free survival per IMWG; Part 2: Minimal Residual Disease negative CR rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov